Bridging the Gap Between Project Management and Validation Management: How to Foster Collaboration

In industries where strict regulations and high-quality standards apply – such as pharmaceutical production, collaboration between project management and validation management plays a crucial role. Yet, a gap often exists between these disciplines. Let’s explore the causes of this gap and offers practical solutions to foster collaboration. 

The Gap: Causes and Challenges 

• Different Priorities 

• Project Management focuses on meeting milestones within defined timelines and budgets. Efficiency and speed are often the priority. 

• Validation Management is dedicated to ensuring compliance and quality, where thoroughness may take precedence over speed. 

This difference in priorities can create tension, especially when project managers push to meet deadlines while validation teams require additional time for checks. 

• Communication Issues 

Poor information transfer: Documentation and results are not always shared promptly or with the proper stakeholders, leading to delays. 

• Silo Thinking 

Teams often operate in isolation, with project managers viewing validation as an “end step” rather than an integral part of the project. 

Validation teams sometimes feel excluded from early decision-making, resulting in inefficiencies. This begins with lack of validation participation in the workshops where user requirements are defined. 

Solutions: Building Bridges 

• Create Shared Goals 

Define project goals that combine time, budget, and quality considerations. For example: "Launch a product within six months with full validation certification." 

Use Key Performance Indicators (KPIs) that reflect shared responsibilities. 

• Improve Communication 

Introduce common tools, such as project management software where validation tasks are visible and linked to project milestones. 

Organize regular cross-functional meetings to discuss progress. 

• Integrate Validation Early 

Involve validation teams from the start of the project, such as during the design phase. This helps identify potential pitfalls early. 

Ensure that validation tasks and deliverables are included in project planning, during each system life cycle phase, to avoid surprises at the end of the process. 

Use templates and guidelines for deliverable like user requirements and test documents so proper documentation principles are followed. 

Ensure your procedures have validation in mind. 

• Invest in Training and Understanding 

Conduct training sessions where project managers learn about validation requirements, and validation teams gain insights into project management principles. 

Create understanding by temporarily placing employees in each other’s roles or organizing shadowing opportunities. 

Conclusion 

The gap between project management and validation management can be bridged through shared goals, improved communication, and early integration of validation into project phases. By viewing these disciplines as partners rather than separate entities, teams can work more efficiently while meeting the highest quality standards. For organizations in regulated industries, strengthening this collaboration is not just a practical choice but a strategic necessity. 

Action Point: Start today by evaluating the collaboration between your project management and validation teams. Where are the biggest bottlenecks, and which of the above strategies can be implemented immediately?